BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2955084 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01673
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/14/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE PUMP BLACK BOX HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A LOW BLOOD GLUCOSE DOWN TO 40 MG/DL WITH "FEELING MENTALLY UNCLEAR" DURING THE PAST WEEK. THE PATIENT REPORTED TREATING THE BLOOD GLUCOSE WITH ORAL CARBOHYDRATE AND THE BLOOD GLUCOSE RESOLVED TO 80 MG/DL; THE PATIENT REPORTED NO FURTHER LOW BLOOD GLUCOSE. THE PATIENT REPORTED TESTING BLOOD GLUCOSE AT 65 MG/DL, ATE ORAL CARBOHYDRATE; THE PATIENT REPORTED THAT PARAMEDICS WERE CALLED BY A FAMILY MEMBER AND THE PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE IN THE 40'S MG/DL. THE PATIENT CONFIRMED THAT ALL OF THE PUMP SETTINGS WERE CORRECT AND DECLINED A FULL REVIEW OF THE PUMP. THE PATIENT STATED THAT A HEALTH CARE PROFESSIONAL WOULD BE ADVISED ABOUT THE EVENT TO SEE IF BASAL RATES NEEDED TO BE ADJUSTED DURING THE NIGHT. THE PATIENT CONFIRMED NO PRIMING OF THE PUMP OR ADJUSTING OF THE CARTRIDGE CAP WHILE ATTACHED AT THE SKIN SITE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59337 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R